MORPHINE SULFATE solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

MORPHINE SULFATE (UNII: X3P646A2J0) (MORPHINE - UNII:76I7G6D29C)

Tillgänglig från:

Tris Pharma Inc

INN (International namn):

MORPHINE SULFATE

Sammansättning:

MORPHINE SULFATE 10 mg in 5 mL

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Morphine Sulfate Oral Solution 2 mg/mL is indicated for the management of: - adults with acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Oral Solution 20 mg/mL is indicated for the relief of acute and chronic pain in opioid-tolerant adult patients . Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.2 ) ], reserve Morphine Sulfate Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated, Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Have not provided adequate analgesia, or are not expected to provide adequate analgesia. Pediatric use information is approved for Hikma Pharmaceutic

Produktsammanfattning:

Morphine Sulfate Oral Solution: 10 mg per 5 mL (2 mg/mL) Oral Solution is supplied as a green, clear solution available as follows: Each 1 mL of green, clear oral solution contains 2 mg of morphine sulfate, USP (equivalent to 1.5 mg morphine). 100 mg per 5 mL (20 mg/mL) Oral Solution (colorless) (only for opioid tolerant adults) is supplied as a clear, colorless to very faint yellow solution. Each 1 mL of clear, colorless to very faint yellow oral solution contains 20 mg of morphine sulfate, USP (equivalent to 15 mg morphine). Storage Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP. Light Sensitive: Protect from light. Store in carton, away from direct sunlight. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Store Morphine Sulfate Oral Solution securely and dispose of properly [see Patient Counseling Information (17) ].

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Tris Pharma Inc
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MEDICATION GUIDE
MORPHINE SULFATE (mor’feen sul’fate) Oral Solution, CII
Morphine Sulfate Oral Solution is:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage short
term (acute) pain in adults and long term (chronic) pain in adults
severe enough to require an opioid
pain medicine, when other pain treatments such as non-opioid pain
medicines do not treat your pain
well enough or you cannot tolerate them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse,
and misuse that can lead to death.
Important information about Morphine Sulfate Oral Solution:
•
Get emergency help or call 911 right away if you take too much
Morphine Sulfate Oral Solution
(overdose). When you first start taking Morphine Sulfate Oral
Solution, when your dose is changed,
or if you take too much (overdose), serious or life-threatening
breathing problems that can lead to
death may occur.
•
Talk to your healthcare provider about naloxone, a medicine for the
emergency treatment of an
opioid overdose.
•
Taking Morphine Sulfate Oral Solution with other opioid medicines,
benzodiazepines, alcohol, or
other central nervous system depressants (including street drugs) can
cause severe drowsiness,
decreased awareness, breathing problems, coma, and death.
•
Never give anyone else your Morphine Sulfate Oral Solution. They could
die from taking it. Selling
or giving away Morphine Sulfate Oral Solution is against the law.
•
Store Morphine Sulfate Oral Solution securely, out of sight and reach
of children, and in a location
not accessible by others, including visitors to the home.
Do not take Morphine Sulfate Oral Solution if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
•
an allergy to morphine.
Before taking Morphine Sulfate Oral Solution, tell your healthcare

Produktens egenskaper

MORPHINE SULFATE- MORPHINE SULFATE SOLUTION
TRIS PHARMA INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MORPHINE SULFATE ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MORPHINE SULFATE
ORAL SOLUTION.
MORPHINE SULFATE ORAL SOLUTION, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1941
WARNING: RISK OF MEDICATION ERRORS: ADDICTION, ABUSE, AND MISUSE; RISK
EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING
RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME;
AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING
MORPHINE
SULFATE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG AND
ML, AND OTHER
MORPHINE SOLUTIONS OF DIFFERENT CONCENTRATIONS CAN RESULT IN
ACCIDENTAL OVERDOSE AND
DEATH. (2.1, 5.1)
MORPHINE SULFATE ORAL SOLUTION EXPOSES USERS TO RISKS OF ADDICTION,
ABUSE, AND
MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK
BEFORE
PRESCRIBING AND MONITOR REGULARLY FOR THESE BEHAVIORS AND CONDITIONS.
(5.2)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.3)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR
CLOSELY, ESPECIALLY UPON INITIATION OR FOLLOWING A DOSE INCREASE.
(5.4)
ACCIDENTAL INGESTION OF MORPHINE SULFATE ORAL SOLUTION, ESPECIALLY BY
CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF MORPHINE. (5.4)
PROLONGED USE OF MORPHINE SULFATE ORAL SOLUTION DURING PREGNANCY CAN
RESULT IN
NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF
NOT
RECOGNIZED AND TREATED. IF PROLONGED OPIOID USE IS REQUIRED IN A
PREGNANT WOMAN,
ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME
AND ENSURE
THAT